Focal Ablation With Focal Cryotherapy or HIFU for the Treatment of Men With Localized Prostate Cancer
Part of paid clinical trials in Sacramento, California.
- Sponsor
- Marc Dall'Era, MD
- Study ID
- NCT06178354
- Status
- Recruiting
Conditions
- Localized Prostate Carcinoma
- Stage I Prostate Cancer AJCC v8
- Stage II Prostate Cancer AJCC v8
- Stage IIIA Prostate Cancer AJCC v8
- Stage IIIB Prostate Cancer AJCC v8
Eligibility Criteria
- Sex
- MALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Cryosurgery — PROCEDUREUndergo focal cryotherapy ablation
- High-Intensity Focused Ultrasound Ablation — PROCEDUREUndergo high intensity frequency ultrasound ablation
- Survey Administration — OTHERAncillary studies
Study Details
This clinical trial evaluates the effectiveness of focal ablation with either focal cryotherapy or high intensity frequency ultrasound for the treatment of men with localized prostate cancer. Focal cryotherapy kills tumor cells by freezing them. High intensity frequency ultrasound uses highly focused ultrasound waves to produce heat and destroy tumor cells.
Key Dates
- Start date
- Nov 9, 2023
- Status verified
- Dec 2024
- Primary completion
- Nov 30, 2028
- Completion
- Jun 30, 2029
Study Design
- Enrollment
- 100 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Treatment (cryosurgery, high intensity focused ultrasound)Patients undergo focal cryotherapy or high intensity focused ultrasound on study.
Primary Outcome Measure
Pathologic outcome on surveillance prostate biopsy [ Time Frame: At year 1 and 3 ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of California Davis Comprehensive Cancer Center | Sacramento | California | 95817 | Marc Dall'Era (PRINCIPAL_INVESTIGATOR) |
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